Prosthesis-Related Infections

Patients who take semaglutide at the time of THA experience similar postoperative outcomes to those who do not SAN FRANCISCO, Feb. 12, 2024 /PRNewswire/ -- Ozempic and Wegovy, which both contain the active ingredient semaglutide, have received recent attention in the media and on social platforms for its effectiveness in supporting weight loss. Ozempic, which is approved for people with Type 2 diabetes, has now become a widely accepted choice for weight loss, and Wegovy was approved in 2021 for long-term weight management. According to the American Academy of Orthopaedic Surgeons (AAOS), obesity and diabetes increases a person's risk of having a medical or surgical complication after joint replacement, such as wound healing problems and infection. As the use of semaglutide increases among patients for diabetes and/or weight management, it's important to understand how it can impact postoperative outcomes of joint replacement surgery. Two studies presented at the AAOS 2024 Annual Meeting looked at the use of semaglutide and its impact on outcomes of total hip arthroplasty (THA), finding that patients who take semaglutide at the time of THA experience similar postoperative outcomes to those who do not take the drug. STUDY OVERVIEWS AND OUTCOMES The effect of semaglutide (Wegovy) treatment on postoperative outcomes of THA in patients with obesity: A matched study Utilizing a large comprehensive national database (TriNetX), researchers (co-led by David Momtaz, MPH, a fourth-year medical student at Long School of Medicine – UT Health San Antonio, and Daniel Pereira, MD, orthopaedic surgery resident at Washington University Barnes-Jewish Hospital) compared postoperative complications among obese patients who used semaglutide and underwent THA to patients without prior use of the medication who underwent the same procedure. A total of 616 patients in each cohort were analyzed. The average patient age was 62.7 years, 55% of patients were female and the average BMI was 35.5, which is considered to be obese. The researchers found that postoperative complications after THA are similar between obese patients using semaglutide compared to those who did not. Both cohorts experienced a similar risk of hip arthroplasty revision, prosthesis infection, opioid-related disorders, surgical site infections, mortality, respiratory failure, pulmonary embolism, deep vein thrombosis, postoperative dehydration, cardiovascular comorbidities, shock, and prosthesis dislocations. Semaglutide use prior to THA results in fewer postoperative prosthetic joint infections and readmissions Researchers (led by Matthew Magruder, a third-year resident at Maimonides Health in Brooklyn, NY) sought to evaluate whether diabetic patients who are taking semaglutide at the time of THA demonstrate: 1) fewer medical complications; 2) fewer implant related complications; 3) fewer readmissions; and 4) less costs. They conducted a retrospective query from Jan. 1, 2010, to Oct. 31, 2021, using the administrative claim database (PearlDiver). The findings note that diabetic patients who were taking semaglutide at time of THA: Did not demonstrate statistically significant higher rates of complications compared with controls. Had lower rates of readmission within 90 days of surgery and lower rates of prosthetic joint infection. There was no difference between groups for any other implant related complication and no difference between cohorts for lengths of stay, same-day surgical costs or 90-day episode of care costs. To schedule an interview with an orthopaedic surgeon to learn more about the correlation between musculoskeletal health and obesity, or to hear more about how lifestyle changes can help prevent muscle mass and bone density loss, email [email protected]. # # # 2024 AAOS Annual Meeting Disclosure Statement About the AAOS With more than 39,000 members, the American Academy of Orthopaedic Surgeons is the world's largest medical association of musculoskeletal specialists. The AAOS is the trusted leader in advancing musculoskeletal health. It provides the highest quality, most comprehensive education to help orthopaedic surgeons and allied health professionals at every career level to best treat patients in their daily practices. The AAOS is the source for information on bone and joint conditions, treatments and related musculoskeletal healthcare issues; and it leads the healthcare discussion on advancing quality. Follow the AAOS on Facebook, X, LinkedIn and Instagram. SOURCE American Academy of Orthopaedic Surgeons

WAYNE, Pa., May 02, 2023 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the launch of two new devices designed to enhance PICC insertion procedures and reduce the chance of complications. The new Arrow® VPS Rhythm® DLX Device and NaviCurve™ Stylet are engineered to work together to give Vascular Access Specialists more efficient and predictable PICC placement. The next-generation VPS Rhythm® DLX Device provides real-time catheter tip location information by using the patient’s cardiac electrical activity. The device is also available with an optional integrated ultrasound featuring a Catheter-to-Vessel ratio tool that promotes standardization in vessel measurement. This device works in concert with the Arrow® PICC preloaded with the NaviCurve™ Stylet, providing innovative tip navigation/location technologies. The VPS Rhythm® DLX Device with TipTracker™ Technology eliminates the need for a confirmatory x-ray, helping the clinician insert seamlessly through ultrasound vessel assessment, PICC navigation, to final tip confirmation in the lower third of the superior vena cava.1 Due to the variability of patient vasculature, all PICCs can occasionally have difficulty advancing into the superior vena cava (SVC) on the first attempt. The Arrow® NaviCurve™ Stylet features an anatomical curve and flexible tip that are designed to self-orient to patient anatomy for enhanced PICC advancement into the superior vena cava (SVC) for successful insertion.1 Teleflex conducted extensive research with industry-leading vascular access professionals to design the enhancements featured in the new Arrow® VPS Rhythm® DLX Device, NaviCurve™ Stylet, PICCS, and other insertion accessories. Clinician-inspired updates to the portfolio include: Integratedultrasound(optional) to assist with vascular access Real-timevisualcatheternavigation, featuring a visualization area twice the size of the BD Sherlock 3CG™2,3 Inbenchtoptesting,optimalPICCdroppingintothelowerthirdoftheSVC inasimulatedmodel, with a 90% drop rate on first insertion attempt with the NaviCurve™ Stylet compared to 0% drop rate with market leading PICC from BD1 Premiumkitcomponents available including one-piece, full-body fenestrated drape, ultrasound probe cover with gel, and 3M™Tegaderm™ CHG Securement Dressing “We remain committed to building strong partnerships with our clinicians and hospitals, and these latest advancements in Arrow® Catheter Insertion Technology from Teleflex align with our mutual goal toward zero catheter-related complications. The introduction of our new positioning device and enhanced catheter design complement our proprietary Arrowg+ard Blue Advance® PICC antimicrobial and antithrombogenic protection that reduces thrombus accumulation and the primary pathogens responsible for most healthcare associated infections.4 With multiple levels of protection, critical innovations, best-in-class education and bedside support, we are well suited to be the partner of choice for our customers.” said Lisa Kudlacz, President and General Manager, Vascular at Teleflex. AboutTeleflexIncorporated Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular access, interventional cardiology and radiology, anesthesia, emergency medicine, surgical, urology and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com. Teleflex is the home of Arrow®, Deknatel®, LMA®, Pilling®, QuikClot®, Rüsch®, UroLift®, and Weck® – trusted brands united by a common sense of purpose. Forward-LookingStatements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to several risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K. References: Data on file: D041679 Benchtop Stylet Advancement in a Simulated Use Anatomical Model of NaviCurve™ Product Stylet/PICC Assemblies. Bench testing may not be indicative of clinical performance. ADHX-001612: Design History File Index for VPS Rhythm® DLX SystemSherlock 3CG+Tip Confirmation System for use with Site~Rite 8 Ultrasound System Instructions for Use, Page 24. Available here: Antimicrobial – In vitro data on AVER-004371, AVER-004483, AVAR-000427. No correlation between in vitro / in vivo testing methods and clinical outcomes have currently been ascertained. Antithrombogenic ‐ As compared to uncoated PICCs, intravascular ovine model inoculated with Staph aureus: AVAR‐000427. No correlation between in vitro / in vivo testing methods and clinical outcomes have currently been ascertained. Rxonly Contraindication: Clinical assessment of the patient must be completed to ensure no contraindications exist. The Arrowg+ard Blue Advance® PICC is contraindicated in the following areas: Patients with known hypersensitivity to chlorhexidine In presence of device related infections In presence of previous or current thrombosis in the intended vessel or along the catheterized vessel pathway. No correlation between invitro/invivo testing methods and clinical outcomes have currently been ascertained. Tegaderm is a registered trademark of 3M or its affiliates. Teleflex, theTeleflex logo, Arrow, Arrowg+ardBlueAdvance, Deknatel, LMA, NaviCurve, Pilling, QuikClot, Rusch, TipTracker, UroLift, VPS Rhythm, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. All other marks are the property of their respective owners. © 2023 TeleflexIncorporated.Allrightsreserved.MC-008720 Contacts: Teleflex Incorporated: Lawrence Keusch Vice President, Investor Relations and Strategy Development investors.teleflex.com 610-948-2836

Major medtech players presented a range of intriguing studies at a gathering of some of the biggest names in the cardiology tech space. Some of the hottest topics were covered this past week at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology (ACC.23/WCC) in New Orleans. Ablation, cardiac implants, monitors and imaging technology represented a handful of the technologies on display. Medtronic, Abbott, Boston Scientific, Edwards and more offered new data on their innovative technologies in these areas. Here are some of the biggest stories that came out of the cardiology conference. Excitement builds around using pulsed-field ablation to treat AFib Medtronic, Boston Scientific and Johnson & Johnson MedTech’s Biosense Webster all released news about their ablation systems. Boston Scientific completed the first enrollment in its Advantage AF clinical trial evaluating the Farapulse PFA system. Farapulse uses pulsed-field ablation to treat persistent AFib. Boston Scientific expects positive trial outcomes to support FDA approval. Medtronic then announced that its PulseSelect pulsed-field ablation (PFA) system exceeded its safety performance goal in a clinical trial. The Pulsed AF trial exceeded the threshold for its efficacy performance goal for the treatment of AFib, too. Finally, Biosense Webster announced the first cases with its investigational Thermocool SmartTouch SF dual energy catheter for treating AFib. The system enables doctors to toggle between PFA and radiofrequency ablation. It could compete against another ablation device in Medtronic’s portfolio — the Sphere-9 system. That came as part of Medtronic’s $1 billion acquisition of Affera, completed in August 2022. Analysts also had their say on the prevalence of ablation technologies. “We expect PFA technologies to be adopted quickly, as so far they seem to be faster and safer than thermal ablation approaches, and the single-shot approach to pulmonary vein isolation (PVI) is likely to take share from cryoablation,” BTIG analyst Marie Thibault wrote in a report. “Whether efficacy will be improved is still an open question. We remain bullish on PFA as a technology class and note there are several other public and private players developing competing approaches.” Abbott’s MitraClip, TriClip both perform well Late-breaking data at ACC supported both Abbott’s MitraClip and TriClip offerings. Five-year data from the COAPT trial highlighted the safety and efficacy of MitraClip for people with mitral regurgitation (MR). Abbott observed a significantly reduced risk of annual hospitalizations (33% per year for MitraClip against 57% in the control). MitraClip also reduced the risk of death by almost 30% (57% vs. 67%) and achieved durable MR reduction. Reduced MR occurred in 95% of patients. Data also demonstrated the superiority of the TriClip transcatheter edge-to-edge repair (TEER) system. The Triluminate pivotal study evaluated TriClip against medical therapy in patients with tricuspid regurgitation (TR). Abbott said TriClip demonstrated a significant reduction in TR grade in 87% of patients at 30 days. That compares to 4.8% in the control. TR reduction registered as sustained and durable at one year. TAVR remains a point of intrigue Edwards Lifesciences, one of the main players in the transcatheter aortic valve replacement (TAVR) space, analyzed 10 years of Medicare data, and its findings backed the replacement heart valve procedure. The analysis showed a low rate of re-intervention after TAVR out to 10 years. Of 230,644 patients treated with transfemoral and transapical TAVR between 2011 and 2021, only 1,880 underwent valvular re-intervention. This translated to a 1.63% rate of re-intervention overall when considering the competing risk of death. “Certainly, more data are needed, but this is definitely reassuring,” said Suzanne Baron, a Boston-based interventional and structural cardiologist who led the analysis. In other TAVR news, three-year data supported the Medtronic Evolut TAVR implant. Findings showed the strength of Evolut against surgical aortic valve replacement (SAVR). Evolut showed significantly better hemodynamic valve performance compared to SAVR. The study evaluated a low-risk aortic stenosis (AS) patient population. iRhythm’s wearable ECG stacks up against the field Multiple new studies supported the use of iRhythm’s  Zio XT wearable heart monitoring technology. iRhythm’s Camelot study used Medicare data to compare the effectiveness of ambulatory monitors for arrhythmia diagnosis. It demonstrated that long-term continuous monitoring with iRhythm Zio XT is associated with the highest diagnostic yield and fastest time to clinical diagnosis compared to all other ambulatory cardiac monitors (ACMs) when looking at specified arrhythmias. “Camelot shows how consequential choosing the right monitoring service can be, from achieving a faster clinical diagnosis leading to reduced repeated testing all the way to lower emergency and inpatient health care utilization and lower costs,” said Dr. Mintu Turakhia, CMO and CSO at iRhythm. Other data demonstrated improved monitoring and decision-making with iRhythm’s next-generation Zio. The company said it also found in another study that non-sustained ventricular tachycardia was independently associated with increased mortality. iRhythm said it may act as a proxy biomarker for cardiovascular risk. Philips showcases cardiology tech portfolio Philips presented an array of clinical results, including trends with intravascular imaging, early cardiac implant removal and intracardiac echocardiography catheters. One study demonstrated that intravascular imaging (IVI) use during PCI procedures as an adjunct to angiography rose by 62% during a seven-year period. Researchers associated this rise with superior patient outcomes. Another study highlighted a major gap in care among cardiac implantable electronic device infection patients, which results in higher mortality, more health care utilization, and higher cost of care. Finally, the company observed both safety and efficacy for its Philips VeriSight Pro 3D ICE intracardiac echocardiography catheter in image-guided, minimally invasive cardiac procedures. “The positive clinical study results announced are further evidence of how we are continuously working with our clinical partners to co-create new innovations and demonstrate how they improve outcomes for patients,” said Dr. Atul Gupta, CMO for image-guided therapy at Philips.